Health Outcomes/Cost of Early vs Delayed ART in Haiti

海地早期 ART 与延迟 ART 的健康结果/成本

• 批准号: 7286030
• 负责人: SERENA Patricia KOENIG
• 金额: $ 12.04万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7286030
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Benefits and Risks; CD4 Lymphocyte Count; Caribbean region; Caring; Cells; Clinical; Clinical Management; Clinical Trials; Clinical effectiveness; Communicable Diseases; Communities; Complex; Consensus; Cost Analysis; Cost Effectiveness Analysis; Country; Data; Decision Modeling; Developing Countries; Development; Disease; Disease model; Drug Formulations; Drug resistance; Enrollment; Financial cost; Funding; Goals; Guidelines; HIV; Haiti; Health; Health Care Costs; Hospitals; Inequality; Infection; International; International AIDS; Intervention; Interview; Knowledge; Lamivudine/Zidovudine; Life; Life Expectancy; Living Costs; Malaria; Measures; Medical; Mentors; Numbers; Outcome; Outcome Measure; Outcome Study; Patients; Pharmaceutical Preparations; Physicians; Policies; Policy Maker; Public Health; Purpose; Quality of life; Quality-Adjusted Life Years; Questionnaires; Randomized; Randomized Controlled Trials; Range; Rate; Research; Research Proposals; Resources; Schedule; Social Medicine; Societies; Staging; State Government; Time; Toxic effect; Tuberculosis; United States; United States Dept. of Health and Human Services; Week; Woman; World Bank; World Health Organization; antiretroviral therapy; base; cohort; cost; cost effectiveness; design; disability-adjusted life years; efavirenz; fighting; follow-up; improved; member; scale up; skills; tool; treatment planning

DESCRIPTION (provided by applicant): There is debate regarding the optimal time to initiate antiretroviral therapy (ART) in resource-limited settings. The research goal of Dr. Serena Koenig, an infectious disease fellow and associate physician in the Division of Social Medicine and Health Inequalities at Brigham and Women's Hospital, is to determine the optimal time to initiate ART in patients with symptomatic HIV disease in Haiti using a decision modeling approach to incorporate complex trade-offs among clinical benefits, risk of toxicity, and financial cost. She will carry out the proposed health outcomes study in parallel with a randomized control trial that will be conducted by the GHESKIO research center in Port au Prince to compare survival and TB outcomes for early versus delayed treatment of patients with pre-AIDS symptomatic HIV disease. She will be mentored by Drs. Sue Goldie, Warren Johnson, and Jean William Pape. This research plan is composed of three specific aims: 1. To measure quality of life and adherence to ART among patients in the early and delayed treatment groups in the clinical trial, and to conduct an interview study of patients and other members of the Haitian community to compare the values they place on health at different stages of HIV disease. 2. To perform a cost analysis of HIV care in Haiti using clinical trial data and retrospective data collected on patients treated at GHESKIO and elsewhere in Haiti. This analysis will estimate the initial, induced, and averted costs of health-care resources over time for early versus delayed ART. 3. To conduct a cost-effectiveness analysis of early versus delayed ART in Haiti from a societal perspective. Outcome measures will include life expectancy, lifetime total direct medical costs, and costeffectiveness in dollars per quality-adjusted life-year gained and in disability-adjusted life-year gained. Results will be stratified based on the presence or absence of active tuberculosis (TB) infection and sensitivity analyses will examine the impact of adherence rates.

描述（由申请人提供）：关于在资源有限的环境中开始抗逆转录病毒治疗（ART）的最佳时间存在争议。 Serena Koenig 博士是布莱根妇女医院社会医学和健康不平等部门的传染病研究员兼副医师，她的研究目标是通过决策建模方法，结合临床获益、毒性风险和财务成本之间的复杂权衡，确定海地有症状 HIV 患者开始 ART 的最佳时间。她将与太子港 GHESKIO 研究中心开展的一项随机对照试验同时进行拟议的健康结果研究，以比较艾滋病前期症状性 HIV 疾病患者的早期治疗与延迟治疗的生存率和结核病结果。她将受到博士的指导。苏·戈尔迪、沃伦·约翰逊和让·威廉·佩普。该研究计划由三个具体目标组成： 1. 衡量临床试验中早期和延迟治疗组患者的生活质量和对 ART 的依从性，并对患者和海地社区其他成员进行访谈研究，比较他们在艾滋病毒疾病不同阶段对健康的价值观。 2. 利用临床试验数据和对在 GHESKIO 和海地其他地方接受治疗的患者收集的回顾性数据，对海地的艾滋病毒护理成本进行分析。该分析将估计早期与延迟 ART 的初始、诱发和避免的医疗资源成本随时间的变化。 3. 从社会角度对海地的早期抗逆转录病毒疗法与延迟抗逆转录病毒疗法进行成本效益分析。结果指标将包括预期寿命、终生总直接医疗费用以及每增加质量调整生命年和增加伤残调整生命年的成本效益（以美元计）。结果将根据是否存在活动性结核病 (TB) 感染进行分层，敏感性分析将检查依从率的影响。